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    Summary
    EudraCT Number:2020-000791-38
    Sponsor's Protocol Code Number:WA42293
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-01-19
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2020-000791-38
    A.3Full title of the trial
    A PHASE III RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF PRM-151 IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate the Efficacy and Safety of PRM-151 in Patients with Idiopathic Pulmonary Fibrosis
    A.4.1Sponsor's protocol code numberWA42293
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorF. Hoffmann-La Roche Ltd
    B.1.3.4CountrySwitzerland
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportF. Hoffmann-La Roche Ltd
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF. Hoffmann-La Roche Ltd
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.6E-mailglobal.rochegenentechtrials@roche.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/12/1020
    D.3 Description of the IMP
    D.3.1Product nameRecombinant human Pentraxin-2 (PRM-151)
    D.3.2Product code RO7490677
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRecombinant human Pentraxin-2
    D.3.9.3Other descriptive namePRM-151
    D.3.9.4EV Substance CodeSUB182526
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Idiopathic pulmonary fibrosis (IPF)
    E.1.1.1Medical condition in easily understood language
    IPF is a chronic and irreversible lung disease. Because of the progressive nature of the disease, lung function deteriorates over time ultimately leading to death.
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10021240
    E.1.2Term Idiopathic pulmonary fibrosis
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate superiority of 10 mg/kg PRM-151 + standard of care (SOC) treatment as needed administered every 4 weeks (Q4W) via intravenous (IV) infusion, over matching placebo + SOC treatment as needed, on lung function on the basis of absolute change from baseline to Week 52 in forced vital capacity (FVC)
    E.2.2Secondary objectives of the trial
    To evaluate:
    • Superiority of 10 mg/kg PRM-151 + SOC treatment as needed administered Q4W via IV infusion, over matching placebo + SOC, on lung function on the basis of absolute change from baseline to Week 52 in 6-minute walk distance (6MWD), FVC, progression-free survival, time to first respiratory-related hospitalizations, change from baseline to Week 52 in University of California, San Diego-Shortness of Breath Questionnaire (UCSD-SOBQ), change from baseline to Week 52 in St. George Respiratory Questionnaire (SGRQ) total score, time to first acute exacerbation of IPF, or suspected acute exacerbation of IPF, change from baseline to Week 52 in carbon monoxide diffusing capacity (DLCO)and survival
    • Safety, tolerability of 10 mg/kg of PRM-151 administered Q4W via IV infusion + standard of care treatment as needed relative to matching placebo + SOC as needed in a population of all dosed patients
    • Pharmacokinetics of PRM-151 in patients with IPF
    • Immune response to PRM-151
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age 40–85 years
    • Documented diagnosis of IPF per the 2018 American Thoracic Society / European Respiratory Society / Japanese Respiratory Society / Latin American Thoracic Society Clinical Practice Guideline
    • High-resolution computed tomography pattern consistent with the diagnosis of IPF, confirmed by central review of Chest HRCT and central review of any available lung biopsy (LB)
    • Minimum 6MWD of 150 meters with maximum use of 6 L/min at sea-level and up to 8 L/min at altitude of supplemental oxygen while maintaining oxygen saturation of >= 83% during the 6MWT during screening
    • FVC >= 45% predicted during screening
    • Forced expiratory volume in 1 second (FEV1)/FVC ratio > 0.70 during screening
    • DLCO >= 30% and <= 90% of predicted during screening
    • If receiving pirfenidone or nintedanib treatment for IPF, the patient must have been on treatment for at least 3 months and on a stable dose for at least 4 weeks prior to screening and during screening
    • If not currently receiving nintedanib or pirfenidone treatment must have discontinued such treatment >= 4 weeks prior to screening and during screening
    • For women of childbearing potential: agreement to remain abstinent or use contraception, women must remain abstinent or use contraceptive methods with a failure rate of < 1% per year during the treatment period and for 8 weeks after the final dose of PRM-151
    • For men: agreement to remain abstinent or use a condom, and agreement to refrain from donating sperm, with a female partner of childbearing potential or pregnant female partner, men must remain abstinent or use a condom during the treatment period and for 8 weeks after the final dose of PRM-151 to avoid exposing the embryo. Men must refrain from donating sperm during this same period
    • Anticipated life expectancy of at least 12 months at baseline, according to the investigator’s judgment
    • Patient and investigator considered all medicinal treatment options and/or possibly lung transplantation prior to considering participation in the study. If the patient is on a lung transplant list, the investigator anticipates the patient will be able to complete the study prior to transplant
    • For patients enrolled in the extended China enrollment phase at NMPA-recognized sites: current resident of mainland China, Hong Kong, or Taiwan, and of Chinese ancestry
    E.4Principal exclusion criteria
    • Evidence of other known causes of interstitial lung disease
    • FVC% predicted value showing improvement in the 6-month period prior to screening and including screening value, as assessed by the investigator Emphysema present on >= 50% of the HRCT, or the extent of emphysema is greater than the extent of fibrosis, according to central review of the HRCT
    • Receiving nintedanib in combination with pirfenidone
    • Received cytotoxic, immunosupressive, cytokine modulating, or receptor antagonist agents within 4 weeks of screening
    • Receiving systemic corticosteroids equivalent to prednisone > 10 mg/day or equivalent within 2 weeks prior to screening
    • Receiving strong inhibitor or inducer of CYP1A2 in patients taking pirfenidone
    • Receiving potent inhibitor or inducer of P-gp in patients taking nintedanib
    • Acute respiratory or systemic bacterial, viral, or fungal infection either during screening or prior to screening and not successfully resolved 4 weeks prior to screening visit
    • Patients with active or latent tuberculosis (confirmed within the 6 months prior to or during screening, by a positive screening test [interferon gamma release assay])
    • Patients who have completed treatment for active or latent tuberculosis within 6 months prior to screening, and have no evidence of recurrent disease, do not need to be tested
    • Resting oxygen saturation of < 89% using up to 4 L/min of supplemental oxygen at sea level and up to 6 L/min at altitude during screening
    • Co-existing acute or chronic medical condition that, in the investigator’s opinion, would substantially limit the ability to comply with study requirements or may influence any of the safety or efficacy assessments included in the study
    • Class IV New York Heart Association chronic heart failure
    • Historical evidence of left ventricular ejection fraction < 35%
    • Presence of pulmonary hypertension that, in the investigator’s opinion, would substantially limit the ability to comply with study requirements or may influence any of the safety or efficacy assessments included in the study
    • Cardiopulmonary rehabilitation program based on exercise training that has been completed within 8 weeks prior to screening or planned to start during the patient’s enrollment in this trial
    • History of a malignancy within the 5 years prior to screening, with the exception of basal cell or squamous cell skin neoplasms. In addition, a malignant diagnosis or condition that occurred more than 5 years prior to screening, and any basal cell or squamous cell neoplasm must be considered cured, inactive, and not under treatment
    • Known post-bronchodilator response in FEV1 and/or FVC >= 12% and >= 200 mL, respectively
    • Receipt of an investigational drug within 4 weeks, or 5 half-lives, whichever is longer, prior to screening
    • Previous treatment with PRM-151
    • Clinically significant abnormality on ECG during screening
    • Pregnant or breastfeeding, or intending to become pregnant during the study or within 8 weeks after the final dose of PRM-151
    E.5 End points
    E.5.1Primary end point(s)
    1. Absolute change from baseline to Week 52 in FVC [mL]
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. From baseline (Day 1) to Week 52
    E.5.2Secondary end point(s)
    1. Absolute change from baseline to Week 52 in 6MWD
    2. Absolute change from baseline to Week 52 in FVC% predicted
    3. Progression-free survival
    4. Time to first respiratory-related hospitalizations
    5. Change from baseline to Week 52 in UCSD-SOBQ
    6. Change from baseline to Week 52 in SGRQ Total Score
    7. Time to first acute exacerbation of IPF, or suspected acute exacerbation of IPF
    8. Change from baseline to Week 52 in DLCO
    9. Survival, as measured by all-cause mortality
    10. Incidence and severity of adverse events, with severity determined according to the 5-point severity scale (National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 [NCI CTCAE, v.5.0])
    11. Incidence and severity of IRRs and other adverse events of special interest
    12. Proportion of patients permanently discontinuing study treatment due to adverse events
    13. Change from baseline in targeted clinical laboratory test results
    14. Plasma concentrations of PRM-151 at specified timepoints
    15. Prevalence of anti-drug antibodies (ADAs) at baseline and incidence of ADAs during the study
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-2. From baseline to Week 52
    3-4. Up to 2.5 years
    5-6. From baseline to Week 52
    7. Up to 2.5 years
    8. From baseline to Week 52
    9-12. Up to 2.5 years
    13. From baseline to 2.5 years
    14. Day 1, 5 and Weeks 4, 12, 24, 36, 48 and 52 or treatment discontinuation visit and Week 56 and unscheduled visits
    15. Day 1 and Weeks 4, 12, 24, 36, 48 and 52 or treatment discontinuation visit and Week 56 and unscheduled visits
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity, Biomarker, Health Status Utility
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA160
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Brazil
    Canada
    China
    Hong Kong
    Israel
    Korea, Republic of
    Mexico
    New Zealand
    Peru
    Russian Federation
    Singapore
    South Africa
    Taiwan
    Turkey
    Ukraine
    United States
    Austria
    Belgium
    Denmark
    Finland
    France
    Germany
    Hungary
    Italy
    Netherlands
    Norway
    Poland
    Portugal
    Spain
    Sweden
    Switzerland
    United Kingdom
    Czechia
    Argentina
    Greece
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of this study is defined as the date when the last patient, last visit (LPLV) occurs or safety follow-up is received from the last patient whichever occurs later.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 178
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 480
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 263
    F.4.2.2In the whole clinical trial 658
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    The sponsor will terminate the trial once PRM-151 becomes commercially available. Currently, the Sponsor does not have any plans to provide PRM-151 to patients who have completed the study. The Sponsor may evaluate whether to continue providing PRM-151 in accordance with the Roche Global Policy on Continued Access to
    Investigational Medicinal Product is available at the following website:
    http://www.roche.com/policy_continued_access_to_investigational_medicines.pdf
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-01-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-01-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-02-10
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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